Lilly’s Bebtelovimab Receives EUA to Treat COVID-19

The FDA has issued an Emergency Use Authorization for Eli Lilly and Co.’s bebtelovimab, an antibody that demonstrates neutralization against the Omicron variant.
 
Bebtelovimab can now be used for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients 12 years and older with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, and for whom alternative COVID-19 treatment options are not accessible or clinically appropriate. The authorized dose of bebtelovimab is 175 mg given as an intravenous injection over at least 30 seconds. 
 
The data supporting this EUA are primarily based on analyses from the Phase 2 BLAZE-4 trial evaluating treatment of non-hospitalized patients with mild-to-moderate COVID-19 who were treated with bebtelovimab (175 mg) alone or together with 700 mg bamlanivimab and 1,400 mg of etesevimab. Pseudovirus and authentic virus testing demonstrate that bebtelovimab retains full neutralizing activity against Omicron – currently the predominant variant in the U.S. In addition, pseudovirus testing with bebtelovimab demonstrates that it retains neutralization against all other known variants of interest and concern, including BA.2.
 
As previously announced, Lilly has signed an agreement with the U.S. government to supply up to 600,000 doses of investigational drug bebtelovimab for at least $720 million.